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FDA Announces Recall of Compounded Drug Products from Outsourcing Facility Cantrell Drug Company Due to Serious Deficiencies in Quality and Sterility Assurance

This week, the FDA alerted healthcare professionals and patients not to use drug products produced by Cantrell Drug Company of Little Rock, Arkansas, including opioid products and other drugs intended for sterile injection, that were produced by the company and distributed nationwide. The agency is concerned about serious deficiencies in Cantrell’s compounding operations, including its processes to ensure quality and sterility assurance that put patient safety at risk. Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death.

Healthcare professionals should immediately check their medical supplies, quarantine any drug products from Cantrell Drug Company and not administer them to patients. The FDA urges healthcare professionals who obtained products from Cantrell to make alternative arrangements to obtain medications they administer or dispense to patients from sources that adhere to proper quality standards. Patients who have received any drug product produced by Cantrell and have concerns should contact their healthcare professional.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online: www.fda.gov/MedWatch/report
  • Download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

If you need additional information, please contact Allison Madson, manager of regulatory affairs, at amadson@ascrs.org or 703-591-2220.